As reported in JAMA Surgery by Etoh et al, 5-year follow-up of the Japanese phase II/III JLSSG0901 trial has shown noninferiority in relapse-free survival with laparoscopic-assisted distal gastrectomy vs open distal gastrectomy in patients with locally advanced gastric cancer.
Study Details
In the multicenter trial, 502 patients (full analysis set) were randomly assigned between November 2009 and July 2016 to undergo laparoscopic-assisted distal gastrectomy (n = 248) or open distal gastrectomy (n = 254) with D2 lymph node dissection. All procedures were performed exclusively by qualified surgeons. The primary endpoint was 5-year relapse-free survival, with a noninferiority margin for the hazard ratio for laparoscopic-assisted distal gastrectomy vs open distal gastrectomy set at 1.31.
Key Findings
Median follow-up was 67.9 months (interquartile range = 60.3–92.0 months). No significant difference in frequency of postoperative chemotherapy was observed between the two groups.
Five-year relapse-free survival was 75.7% (95% confidence interval [CI] = 70.5%–81.2%) in the laparoscopic-assisted distal gastrectomy group vs 73.9% (95% CI = 68.7%–79.5%) in the open distal gastrectomy group (hazard ratio [HR] = 0.96, 90% CI = 0.72–1.26, P = .03 for noninferiority).
Five-year overall survival was 81.7% (95% CI = 77.0%–86.7%) in the laparoscopic-assisted distal gastrectomy group vs 79.8% (95% CI = 75.0%–84.9%) in the open distal gastrectomy group (HR = 0.83, 95% CI =0.57–1.21, P = .34).
Disease recurrence was observed in 17.7% of the laparoscopic-assisted distal gastrectomy group vs 18.1% of the open distal gastrectomy group. Patterns of recurrence were similar, with the most common sites being lymph node (3.6% vs 6.3%), peritoneum (7.7% vs 4.3%), and liver (2.8% vs 4.7%).
Severe postoperative complications occurred in 3.5% of patients in the laparoscopic-assisted distal gastrectomy group vs 4.7% of those in the open distal gastrectomy group (P = .64). The laparoscopic-assisted distal gastrectomy group had a longer median operating time (291 vs 205 minutes, P < .001) and lower median blood loss (30 vs 141 mL, P < .001). No significant differences between groups were observed for reoperation, readmission, or 30-day or in-hospital mortality.
The investigators concluded, “Results of this study show that on the basis of 5-year follow-up data, laparoscopic-assisted distal gastrectomy with D2 lymph node dissection for locally advanced gastric cancer, when performed by qualified surgeons, was proved noninferior to open distal gastrectomy. This laparoscopic approach could become a standard treatment for locally advanced gastric cancer.”
Tsuyoshi Etoh, MD, PhD, of the Department of Gastroenterological and Pediatric Surgery, Oita University Faculty of Medicine, Oita, is the corresponding author for the JAMA Surgery article.
Disclosure: The study was supported by grants from the Japanese Foundation for Research and Promotion of Endoscopy. For full disclosures of the study authors, visit jamanetwork.com.
